Several hundred thousands of patients receive subcutaneous cardiac devices (pacemakers, defibrillators, resynchronization therapy devices, loop recorders) throughout the world each year, with many thousands in the United States alone. With increasing advances in medical devices and the advent of life saving implantable cardioverter defibrillators along with cardiac resynchronization therapy, cardiac device therapy placed in the chest through the infraclavicular/subclavian approach has become very common. Usually, after sterile preparation, a small incision is made below the clavicle either on the right or left side. A subcutaneous pocket is created, bleeders are secured, and access to the subclavian vein or cephalic vein is obtained under the guidance of fluoroscopy. Then pacing or defibrillator leads may be placed in the appropriate chambers of the heart. These leads may be secured to the fascia over the pectoralis muscle and the end of which may be usually plugged into the ports in the device generator. The portion of the leads and the generator may be placed in the pocket and closed in two or three layers of suture. Bleeders may be secured before closing the pocket. Sterile strips may be placed over the closed incision and allowed to heal over the next few days.
Based on prior research, pocket bleeding and hematoma formation may be seen in about 4.9% patients and the incidence may be higher in those receiving defibrillators compared to pacemakers. Pocket bleeding can prolong hospital stay in 1.5% of patients who receive these devices up to 2.5 days with about 0.5% requiring repeat hospitalization and close to 1% needing pocket revision and hematoma evacuation. The risk of post device bleeding and hematoma formation may be significantly higher (e.g., up to 12%-20%) in those patients who may be bridged with anticoagulants like heparin and enoxaparin. Even in those cases where warfarin is continued throughout the procedure, the risk of post procedural bleeding may be up to 2-6%. Often, large hematomas and subsequent evacuations lead to increased incidence of infection.
Commonly, small swelling or hematoma left untreated and healing are left to normal body processes. However, hematomas and pocket bleeding can be serious enough in a certain percentage of patients as described above, requiring immediate attention. This can significantly increase the cost of treatment, and the amount of lost wages. This can also add a significant morbidity to the patient's health. Patients with device site hematomas and bleeding are at higher risk for infections which often require hospitalizations, intravenous antibiotic therapy and device extraction that leads to significant procedural risks, costs and patient comfort